Enhancing Oral Cancer Awareness

NCT06682494 | Recruiting

• 2 other identifiers: MCC-24-21890HM20030494
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention

Conditions

Oral Cancer; Chatbot; Patient Education; Prevention; Oropharyngeal Cancers; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer

Keywords

AI-powered Chatbox; Oral cancer prevention; Socio-economic barriers

Outcome Measures

Primary Outcomes (4)

• Compare participant retention rates between the AI-powered tool arm and the conventional educational material arm

  Compare the percentage of participants that continued the intervention to the participants that continued using the active comparator to measure intervention feasibility.

  Baseline, and post intervention (3 months)

• Evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on knowledge and behavior

  Assess the effectiveness of the interventions by baseline and post intervention surveys assessing oral cancer knowledge, attitudes, and behaviors utilizing a questionnaire based on the Health Belief Model. The questionnaire will include scales measuring knowledge about oral cancer, its causes, risk factors, signs, preventive methods. Each question will have one correct answer, and the final score at baseline and after the intervention will be compared. Based on previous literature, a score of 60-70% can indicate adequate knowledge about a disease, but the primary goal of the outcome is to compare improvement in knowledge between control vs intervention arms.

  Baseline, and post intervention (3 months)

• Investigate socio-demographic factors that affect oral cancer knowledge in the African American population

  Pre-intervention surveys will include questions assessing socio-demographic variables of the participants. These variables will serve as covariates in the analysis to measure their effects on knowledge and attitudes. The effect of demographic factors affecting healthcare service utilization, such as education attainment and health insurance status, on knowledge about and attitude toward oral cancer will be measured through regression analysis to investigate their impact on oral cancer awareness and prevention efforts.

  Baseline, and post intervention (3 months)

• Evaluate the acceptability of AI-powered chatbot interactions versus traditional educational handouts

  Assess the acceptability of the interventions by baseline and post intervention surveys assessing satisfaction, appropriateness, ease of use, and acceptability of the interventions to improve oral cancer knowledge. Satisfaction and acceptability will be measured through a set of questions in the post-intervention questionnaire with 5 Likert scale-based responses ranging from "Strongly Disagree" to "Strongly Agree", and the final score will be compared between arms.

  Baseline, and post intervention (3 months)

Study Arms (2)

Traditional Educational Materials

ACTIVE COMPARATOR

Receiving oral cancer educational materials (handouts from trusted sources such as the Centers for Disease Control (CDC) and American Cancer Association (ACA) and other reliable health education resources.

Behavioral: Traditional Education

Engaging with an AI-powered Chatbot

EXPERIMENTAL

AI-powered chatbox designed specifically for oral cancer education. The chatbot is programmed to provide accurate information on oral cancer risks, symptoms, preventive measures, and the importance of regular dental check-ups.

Behavioral: AI-powered Chatbox

Interventions

AI-powered Chatbox BEHAVIORAL

The chatbot interaction will be initiated through a provided link, allowing participants to access information and ask questions related to oral health and cancer prevention. The chatbot is programmed to provide accurate information on oral cancer risks, symptoms, preventive measures, and the importance of regular dental check-ups. Participants will be encouraged to interact with the chatbot for a specified duration

Engaging with an AI-powered Chatbot

Traditional Education BEHAVIORAL

Participants will receive traditional educational handouts focusing on increasing awareness of oral cancer risks, preventive strategies, and the importance of regular dental check-ups. Participants will be provided time to read the handouts based on calculated reading time.

Traditional Educational Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as African American as defined by the US Census
• Participants must be able to read, speak, and write in English

You may not qualify if:

• Individuals who cannot physically or mentally participate in the research project will be excluded
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Association for Cancer Education: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tamas Gal, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamas Gal, Ph.D

CONTACT

804-628-2123; Tamas.Gal@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 12, 2024
• Study Start: September 24, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 7/1/2025 - 6/30/2030
• Access Criteria: Data will be shared upon request. Requests will be submitted to the PI (Tamas Gal, PhD) through email (Tamas.Gal@vcuhealth.org)

Locations

US (1)